MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BV PULSERA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BV PULSERA
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that during a planned non-emergency treatment procedure, a burning smell was coming from the on/off board.Smoke was detected by the customer and there were visible burn marks on the board.The user stopped using the system and completed the procedure with another system.No harm has been reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.A philips service engineer inspected the system on site and identified that the on/off circuit board had a burned spot which caused the burning smell and smoke.The engineer replaced the mains control unit (which includes the on/off circuit board) and the mains transformer.The system was returned to use in good working order.Corrected data: codes are updated as per the investigation outcome.

• Brand Name: BV PULSERA
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15380065
• Report Number: 3003768277-2022-00414
• Device Sequence Number: 12174401
• Product Code: OWB
• UDI-Device Identifier: 00884838055506
• UDI-Public: 00884838055506
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BV PULSERA
• Device Catalogue Number: 718095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown